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This Study Is To Determine If Inhaled Insulin Is Effective In Treating Type 2 Diabetes Mellitus

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85051 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
30-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Age > 30 years and ≤ 75 years with a diagnosis of type 2 diabetes mellitus made > 6
months prior to study entry

- Screening HbA1c > 7.0%

- Currently treated on a stable dose of at least 2 oral antidiabetic agents for at least
3 months prior to study entry; including a sulfonylurea and/or metformin, and/or a
thiazolidinedione

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

Smoking within last 6 months PFTs outside of range

- Type 1 diabetes mellitus

- Type 2 diabetes mellitus currently (last three months) treated with an insulin regimen
(alone or with Oral Antidiabetic Agents)

- Active liver disease; significantly-impaired hepatic function, as shown by, but not
limited to, alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT)
or aspartate transaminase (AST) serum glutamic-oxaloacetic transaminase (SGOT) above
2x the upper limit of normal as measured at visit 1. However, patients with elevated
ALT >1.5 upper limit of normal as a result of hepatic steatosis are permitted to enter
the study.

NCT00418522
Pfizer
Completed
This Study Is To Determine If Inhaled Insulin Is Effective In Treating Type 2 Diabetes Mellitus

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This Study Is To Determine If Inhaled Insulin Is Effective In Treating Type 2 Diabetes Mellitus
A Six Month, Open Label, Randomized Parallel Group Trial Assessing The Impact Of Dry Powder Inhaled Insulin (Exubera) On Glycemic Control Compared To Insulin Glargine (Lantus) In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On A Combination Of Two Or More Oral Agents
This study is to determine if inhaled insulin is effective in treating type 2 diabetes mellitus.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Insulin glargine
    Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
  • Drug: Inhaled Insulin (Exubera)
    Initiation dose of one mg per meal, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
  • Active Comparator: Insulin glargine
    Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
    Intervention: Drug: Insulin glargine
  • Experimental: Exubera
    Initiation dose of one mg per meal, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
    Intervention: Drug: Inhaled Insulin (Exubera)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
413
August 2008
August 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 30 years and ? 75 years with a diagnosis of type 2 diabetes mellitus made > 6 months prior to study entry
  • Screening HbA1c > 7.0%
  • Currently treated on a stable dose of at least 2 oral antidiabetic agents for at least 3 months prior to study entry; including a sulfonylurea and/or metformin, and/or a thiazolidinedione

Exclusion Criteria:

Smoking within last 6 months PFTs outside of range

  • Type 1 diabetes mellitus
  • Type 2 diabetes mellitus currently (last three months) treated with an insulin regimen (alone or with Oral Antidiabetic Agents)
  • Active liver disease; significantly-impaired hepatic function, as shown by, but not limited to, alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) or aspartate transaminase (AST) serum glutamic-oxaloacetic transaminase (SGOT) above 2x the upper limit of normal as measured at visit 1. However, patients with elevated ALT >1.5 upper limit of normal as a result of hepatic steatosis are permitted to enter the study.
Sexes Eligible for Study: All
30 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
 
 
NCT00418522
A2171095
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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